PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [CVS PHARMACY]

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PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET [CVS PHARMACY]
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NDC 59779-484-02, 59779-484-47, 59779-484-52, 59779-484-62, 59779-484-71, 59779-484-72, 59779-484-76, 59779-484-78, 59779-484-83, 59779-484-85, 59779-484-87, 59779-484-90, 59779-484-93
Set ID 9bf2e992-fbdb-45ae-89e9-e68c4c7cd7d8
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class
Product Number
Application Number PART343
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  • Active ingredient (in each caplet)

    Acetaminophen 500 mg

  • Purpose

    Pain reliever/fever reducer

  • Uses

    •
    temporarily relieves minor aches and pains due to:
    •
    the common cold
    •
    headache
    •
    backache
    •
    minor pain of arthritis
    •
    toothache
    •
    muscular aches
    •
    premenstrual and menstrual cramps
    •
    temporarily reduces fever
  • Warnings

    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

    •
    more than 4,000 mg of acetaminophen in 24 hours
    •
    with other drugs containing acetaminophen
    •
    3 or more alcoholic drinks every day while using this product

    Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

    •
    skin reddening
    •
    blisters
    •
    rash

    If a skin reaction occurs, stop use and seek medical help right away.

    Do not use

    •
    with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
    •
    if you have ever had an allergic reaction to this product or any of its ingredients

    Ask a doctor before use if you have

    liver disease

    Ask a doctor or pharmacist before use if you are

    taking the blood thinning drug warfarin

    Stop use and ask a doctor if

    •
    pain gets worse or lasts more than 10 days
    •
    fever gets worse or lasts more than 3 days
    •
    new symptoms occur
    •
    redness or swelling is present

    These could be signs of a serious condition.

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

  • Directions

    •
    do not take more than directed (see overdose warning)

    adults and children 12 years and over

    •
    take 2 caplets every 6 hours while symptoms last
    •
    do not take more than 6 caplets in 24 hours, unless directed by a doctor
    •
    do not use for more than 10 days unless directed by a doctor

    children under 12 years

    ask a doctor
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    carnauba wax, corn starch*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

    *may contain one or more of these ingredients

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to the active ingredient in Extra Strength Tylenol®

    Caplets

    EXTRA STRENGTH

    Pain Relief

    ACETAMINOPHEN 500 mg

    Pain reliever; Fever reducer

    For adults

    Actual Size

    1000 CAPLETS

    484-17-pain relief.jpg
  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF  EXTRA STRENGTH
    acetaminophen tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-484
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeCAPSULE (caplet) Size16mm
    FlavorImprint Code L484
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-484-711 in 1 CARTON10/07/1992
    150 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:59779-484-781 in 1 CARTON10/07/1992
    2100 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:59779-484-851 in 1 CARTON10/07/199205/15/2015
    3250 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:59779-484-621 in 1 CARTON10/12/1992
    424 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:59779-484-761 in 1 CARTON11/30/1992
    5120 in 1 BOTTLE; Type 0: Not a Combination Product
    6NDC:59779-484-721 in 1 CARTON07/19/200707/19/2007
    660 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:59779-484-931000 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
    8NDC:59779-484-90500 in 1 BOTTLE; Type 0: Not a Combination Product09/15/2015
    9NDC:59779-484-831 in 1 CARTON02/11/2016
    9225 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:59779-484-521 in 1 CARTON08/22/199508/22/1995
    1010 in 1 BOTTLE; Type 0: Not a Combination Product
    11NDC:59779-484-02550 in 1 BOTTLE; Type 0: Not a Combination Product08/03/2016
    12NDC:59779-484-872 in 1 CARTON01/17/2017
    12150 in 1 BOTTLE; Type 0: Not a Combination Product
    13NDC:59779-484-471 in 1 CARTON01/17/2017
    13150 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34307/15/1991
    Labeler - CVS Pharmacy (062312574)
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